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Claims for Patent: ► Subscribe

Title:

Pharmaceutical composition of topiramate

Abstract:

The invention is directed to a pharmaceutical composition of topiramate, an anticonvulsant which is useful for treating epilepsy. More specifically, the present invention provides a solid dosage formulation of topiramate intended primarily for use by pediatric patients, or for patients who have difficulty swallowing tablets. Processes for preparing the pharmaceutical composition are also described.

1. A method of treating convulsions in a mammal in need thereof which comprises administering to the mammal a therapeutically effective amount of a pharmaceutical composition
comprising (a) core particles containing an active agent of topiramate, a binder and a diluent wherein the diluent is sugar spheres and wherein the core particles have an initial particle size between about 0.710 mm and 1.18 mm; and (b) a taste mask
coating, wherein the taste mask coating comprises between about 9% by weight and about 13% by weight of the pharmaceutical composition and wherein the coated particles of the pharmaceutical composition have a final particle size between about 0.850 mm
and 1.18 mm; and wherein the coated particles are sprinkled onto soft food and swallowed.

2. The method of claim 1, wherein the taste mask coating comprises about 11% by weight of the pharmaceutical composition.

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